FDA.reportPublic FDA data

Relaxis

Primary DI
00852335007083
Brand
Relaxis
Company
Relaxis
Model
09-0023-01
Device description
Replacement Power Supply, Relaxis
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVPVibratory Counter-Stimulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVPVibratory Counter-StimulationPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN110011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN110011000SYMPHONY DEVICESensory Medical, Inc.2013-12-18OVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852335007083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852335007083008523350070838523350070830852335007083

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supplyA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 475-7435xx@xx.xx

Regulatory Flags#

DUNS number
963372995
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852335007021Relaxis09-0020-02RF2016-09-22
00852335007038Relaxis09-0020-02RN2016-09-22
00852335007052Relaxis09-0021-022016-09-22
00852335007069Relaxis09-0021-02RF2016-09-22
00852335007076Relaxis09-0021-02RN2016-09-22
00852335007090Relaxis09-0020-022016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852335007021RelaxisRelaxisOVP2016-09-22
00852335007038RelaxisRelaxisOVP2016-09-22
00852335007052RelaxisRelaxisOVP2016-09-22
00852335007069RelaxisRelaxisOVP2016-09-22
00852335007076RelaxisRelaxisOVP2016-09-22
00852335007090RelaxisRelaxisOVP2016-09-22